1- Conceptual & Basic Deign
1.1 Facility drawings
- Site plane indicating the location of the buildings internal roads
- Drawing representing the location of the production area, warehouse of the incoming materials, warehouse of the final products, the location of the quality control laboratories, the location of the utilities plant and the administration building
1.2 Equipment layout
- The location of the production equipment, the location of the process utilities (Purifies
Water, Water For Injection , Clean Stem , )
- The location of the services utilities (Boilers, Compressed air, gas stations, etc)
- The location of the quality control laboratories (Raw material testing laboratories, final
product testing laboratories, sterility testing laboratories, microbiology laboratories, etc)
2- GMP concepts on
2.1 Different flows
- Representing the personnel flow and the gowning areas for production personnel, warehouse personnel and quality control personnel
- Representing the flow of raw materials from the warehouse to the dispensing area then the manufacturing area
- Representing the flow of final products from the production area to the warehouse
- Representing the flow of the waste materials and the place of collection for disposal outside the facility
2.2 Zoning concept
- Drawing representing the different zones (formulation zone, filling zone, material handling zone, etc and the separation air lock between the deferent zones)
3. Standards
3.1 Air cleanliness classes and deferential pressure gradient
- Representing the air cleanliness classes (Class 100, Class 1000, Class 100000, and the gray area
- Different concepts representing the deferential pressure between room/room, room/corridor to assure the air cleanliness and to prevent the cross contamination
- Representing the deferential pressure in case of the formulation and filling of non sterile powder
- Representing the deferential pressure in case of the formulation and filling of sterile powder
- Representing the deferential pressure in case of formulation and filling of sterile
Representing the deferential pressure concept in case of sterility testing laboratories
18(hours)